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ZEJULA

NDA

NIRAPARIB TOSYLATE | N208447 | GLAXOSMITHKLINE LLC

1 strength7 unique patents2 unique exclusivities

Patent Timeline

7 unique patents, 2 exclusivities by expiration date

Active (7)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

Today

Aug. 12, 2027

Mar. 27, 2031

Aug. 12, 2027

Apr. 24, 2029

Aug. 4, 2031

Mar. 27, 2038

Mar. 27, 2038

ODE-277

Oct. 23, 2026

ODE-295

Apr. 29, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents (2 active) from PACER

Case	Court	Filed	Status	Judge
KUDOS PHARMACEUTICALS LIMITED et al v. NATCO PHARMA LIMITED et al 3:2026cv01711 5 patentsANDA 221116niraparib	D.N.J.	2026-02-20	Active	—
KUDOS PHARMACEUTICALS LIMITED et al v. SUN PHARMACEUTICAL INDUSTRIES LIMITED et al 3:2025cv15825 4 patentsANDA 220688niraparib	D.N.J.	2025-09-19	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Zejula (2023)

Total Spending

$161.5M

Total Claims

10,023

Beneficiaries

1,886

Avg Cost/Unit

$396.21

Spending Trend

$91.0M(2019)→$138.6M(2020)→$152.0M(2021)→$154.7M(2022)→$161.5M(2023)

YoY Change:+43.1%

5yr CAGR:+14.6%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain7 active DMFs

7 active API suppliers hold Drug Master Files for this ingredient.

VALARY LAB PRIVATE LTDNIRAPARIB TOSYLATE MONOHYDRATE

DMF 393532024

CHANGZHOU PHARMACEUTICAL FACTORYNIRAPARIB TOSYLATE MONOHYDRATE

DMF 394492024

CIPLA LTDNIRAPARIB TOSYLATE MONOHYDRATE

DMF 408952025

DR REDDYS LABORATORIES LTDNIRAPARIB TOSYLATE MONOHYDRATE

DMF 414552025

PORTON PHARMA SOLUTIONS LTDNIRAPARIB TOSYLATE MONOHYDRATE

DMF 415292025

MSN LABORATORIES PRIVATE LTDNIRAPARIB TOSYLATE

DMF 431572025

BIOPHORE INDIA PHARMACEUTICALS PVT LTDNIRAPARIB TOSYLATE

DMF 433042025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Apr 27, 2023	SUPPL -27	View Letter (PDF)
Dec 9, 2022	SUPPL -25	View Letter (PDF)
Sep 15, 2022	SUPPL -26	View Letter (PDF)
Jul 28, 2021	SUPPL -22	View Letter (PDF)
Jul 28, 2021	SUPPL -24	View Letter (PDF)
Mar 4, 2021	SUPPL -19	View Letter (PDF)
Mar 4, 2021	SUPPL -20	View Letter (PDF)
Jun 2, 2020	SUPPL -18	View Letter (PDF)
Apr 30, 2020	SUPPL -17	View Letter (PDF)
Apr 30, 2020	SUPPL -15	View Letter (PDF)
Feb 27, 2020	SUPPL -12	View Letter (PDF)
Oct 24, 2019	SUPPL -14	View Letter (PDF)
Mar 29, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 100MG BASE

RLD

7 patents2 exclusivities▴

CAPSULE;ORAL | Approved: Mar 27, 2017

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8071579	Aug 12, 2027	—	—	—		—
8071623	Mar 27, 2031	—	Yes	Yes	—	—
8143241	Aug 12, 2027	—	—	—		—
8436185	Apr 24, 2029	—	Yes	—	—	—
8859562	Aug 4, 2031	—	—	—		—
11091459	Mar 27, 2038	—	—	Yes	—	—
11673877	Mar 27, 2038	—	—	Yes		—

Exclusivities (2)

Code	Date	Status
ODE-277	Oct 23, 2026	< 1 year
ODE-295	Apr 29, 2027	< 1 year